Sr. Validation Engineer, Process Validation

Danaher Corporation•Fargo, ND

6d•Onsite

About The Position

The Senior Validation Engineer, Process Validation role is responsible providing expertise, guidance, and maintenance of the Validation programs across biological Critical Starting Materials, Drug Substances, and Drug Products manufactured at Aldevron’s Fargo, ND site. As the subject matter expert in validation, this position leads the development, execution, and implementation of validation, practices, policy, and procedures. This position reports to the VP, Global Technical Operations and is part of the Technical Operations Department located in Fargo, ND and will be an on-site role.

Requirements

Bachelor's degree in Engineering or Scientific field (preferably Chemical, Biology, or Microbiology) with 5+ years of experience or MS degree with 3+ years of experience. PhD in Engineering or Scientific field with 2+ years of experience.
Experience in process development, engineering, and process validation required.
Experience working in CDMO environment is a plus

Nice To Haves

Working knowledge of current industry critical starting material, drug substance, and drug product regulatory guidelines

Responsibilities

Design, execute, and oversee validation documents supporting process characterization and validation spanning biological critical starting materials, drug substance, and drug product
Mentor junior validation associates in Process Validation, cGMP regulations, and principles of Quality by Design
Develop and implement validation policies and procedures based on current regulations and industry standards
Provide subject matter expertise during client and regulatory audits, kaizen and workshop events, and manufacturing support
Help resolve quality issues and CAPA’s leading lab investigations, risk assessments, root cause analysis, and developing implementation plans